Study: Fewer Infants and Toddlers Harmed by Medications After Withdrawal and Label Changes

A little more than six years ago, manufacturers including Dimetapp, Little Colds, Pediacare, Robitussin, Triaminic and Tylenol voluntarily pulled their over-the-counter cough and cold medicines for children under age two from the market. A year later, they adjusted the labels on their products intended for older children, warning against use in any child under age four.

“It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately,” Linda Suydam, D.P.A, president of the Consumer Healthcare Products Association, said at the time. “The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority.”

Now a new study in Pediatrics reports these changes in the marketplace succeeded in reducing the number of emergency department visits for adverse events related to cough and cold medications. The study considered data on adverse drug events collected nation-wide from 2004 to 2011. As you can see in the chart below, the data shows a clear drop in the number of infants and toddlers seeking treatment after taking cold and cough medicines.

Proportion of emergency department adverse drug events due to cough and cold medicines in patients less than two years old.

Before the infant cough and cold medicines were taken off of the market, children under age two made up 4.1% of all emergency visits related to adverse drug events. After the voluntary market withdrawal, that rate dropped to 2.4%. Looking at toddlers ages two to three, similar emergency visits decreased from 9.5% of the total number of adverse drug events to 6.5%.

While any decrease in the number of children harmed by over-the-counter medication is welcome, study authors say accidental overdoses remain a concern. Follow these steps from the CDC’s Up and Away and Out of Sight program to reduce the risk of accidental overdose:

Store medication where children can’t reach it (and remember they can be pretty creative when something is out of reach!).

Put medicines away every time.

Listen for the click and make sure safety caps are locked.

Teach your children about medication safety.

Tell guests about medicine safety.

Be prepared in case of an emergency. Program the number for poison control in your cell phone for quick reference: 800-222-1222.